FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
8593–8616 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 31, 1983
ENDOSCOPIC OVERTUBE
K833268 · FED
Mill-Rose Laboratory
Gastroenterology & Urology · 40d
Cleared Oct 31, 1983
LEIDER FEEDING TUBE W/HYDROMER LUBR
K833293 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 39d
Cleared Oct 27, 1983
HPR HOME PATIENT RENATRON
K833181 · LIF
Renal Systems, Inc.
Gastroenterology & Urology · 38d
Cleared Oct 20, 1983
SILICONE-SILVER PENILE PROSTHESIS-ESK
K830667 · FTQ
Dacomed Corp.
Gastroenterology & Urology · 230d
Cleared Oct 20, 1983
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
K832043 · FAE
Medical Engineering Corp.
Gastroenterology & Urology · 118d
Cleared Oct 19, 1983
PEDIATRIC ILLUMINATING URETERAL
K832807 · FCW
Van-Tec, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 19, 1983
PERCUTANEOUS NEPHROSTOMY CATHETER
K833008 · LJE
Medical Engineering Corp.
Gastroenterology & Urology · 43d
Cleared Oct 19, 1983
GASTRIC SUMP TUBES
K833054 · KNT
Medovations, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 19, 1983
DEFLECTING GUIDE WIRE
K833242 · KNY
Van-Tec, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 14, 1983
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
K831424 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 164d
Cleared Oct 14, 1983
MICROSTAR VCI
K831766 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 135d
Cleared Oct 14, 1983
DUAL FLOW NEEDLE
K832136 · FIE
Travenol Laboratories, S.A.
Gastroenterology & Urology · 105d
Cleared Oct 14, 1983
MICROSTAR VC1 VOLUMETRIC CYCLER
K832141 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 101d
Cleared Oct 14, 1983
SHERIDAN/LEVI-A-SUMP
K832196 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 99d
Cleared Oct 14, 1983
DIALYZER PREPARATION SYS DPS-4
K832230 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 95d
Cleared Oct 14, 1983
URO-TEX MALE EXTERNAL CATHETER
K832450 · KNX
Sierra Laboratories, Inc.
Gastroenterology & Urology · 80d
Cleared Oct 14, 1983
TOP DISPOS. INFUSION SET/HEMODIALY
K832623 · KOC
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 71d
Cleared Oct 14, 1983
NEPHROSS PRESTO
K832666 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 66d
Cleared Oct 14, 1983
URETERAL DILATION SET
K832808 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 14, 1983
CLOSED SYS. DRAINAGE BAGS & TRAYS
K832822 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 14, 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
K832894 · KOC
Gambro, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 14, 1983
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · FAD
Surgitek
Gastroenterology & Urology · 46d
Cleared Oct 14, 1983
GRAVITY ENTERAL FEEDING SET
K832927 · KNT
Medical Connections
Gastroenterology & Urology · 51d
Cleared Sep 29, 1983
STERILE FLUID PRODUCING UNIT #EP550
K832040 · LJH
American Cystocope Makers, Inc.
Gastroenterology & Urology · 97d